Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions. Necropsy was not performed in all surviving animals; 2 instead of 3 dose groups were used. Not performed according to GLP. No analytical purity was given in the study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted in 1987
Deviations:
yes
Remarks:
necropsy was not performed in all surviving animals; 2 instead of 3 dose groups were used
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Solbrol M Na-Salz
- Physical state: solid
- Analytical purity: no data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 9 - 14 weeks
- Weight at study initiation: 179 g (males), 165 g (females)
- Fasting period before study: Animals were fasted in the time between 16 h before and 4 h after the application of the test substance.
- Housing: Animals were housed in groups of 5 in Makrolon III cages with dust-free wood bedding.
- Diet: Altromin R1324, ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1.5
- Humidity (%): 60 ± 5
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 23 Nov 1981
To: 9 Dec 1981

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
Doses:
3100 and 5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: On the treatment day, the animals were observed several times for clinical signs. During the residual time of the study period, observations were made twice daily and on weekends and holidays once daily. Animal body weights were determined weekly.
- Necropsy of survivors performed: yes, on a random basis

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
3100 mg/kg bw: 0/5 males and 0/5 females died.
5000 mg/kg bw: 2/5 males (at 8 and 24 h post-dose) and 0/5 females died
Clinical signs:
3100 mg/kg bw: No clinical signs were observed up to the end of the 14 day observation period.
5000 mg/kg bw: During the first 24 h after application, 5/5 males and 5/5 females layed down in side or prone position and showed signs of sedation. These symptoms were fully reversible within 24 h in all animals. During the residual observation period no symptoms were noted.
Gross pathology:
Necropsy of surviving animals on a radom basis revealed no substance-related findings. No necropsy or histopahological examination was done in the males, died 8 and 24 h post-dose.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified